HYDROCHLOROTHIAZIDE; IRBESARTAN | A077446 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Aurobindo Pharmaceuticals Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2011-P-0743 · 4 docket documents Aurobindo Pharmaceuticals Limited, through EAS Consulting Group LLC, filed this citizen petition on October 11, 2011, requesting that the FDA determine whether Avalide (irbesartan and hydrochlorothiazide) Tablets in the 300 and 25 mg strength, approved under NDA 20-758 and manufactured by Sanofi Ave | 505(q) | 2011-10-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.